NL-OMON44518已完成2 期
A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma - Phase II study of BGJ398 in recurrent glioblastoma
ovartis Pharma B.V.0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1)Patients with histologically confirmed GBM and/or glioma subtypes at the time of diagnosis or prior relapse.
- •2) Documentation of FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, FGFR2, or FGFR3.
- •3) RANO defined tumor progression by MRI in comparison to a prior scan
- •4) Patients must have received prior external beam radiotherapy and temozolomide.;Other protocol defined criteria may apply.
排除标准
- •1) History of another primary malignancy
- •2) Prior or current treatment with a FGFR inhibitor
- •3) Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
- •4) Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.
- •Other protocol defined criteria may apply.
研究者
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